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Implantation with HistopathologyTests

Implantation with HistopathologyTests

The Implantation with Histopathology test determines the local pathological effects of an implanted device. This test allows manufacturers to assess the impact the implanted material has on surrounding tissue and major body organs. Histopathology is necessary to meet the ISO requirements. Implantation tests comply with ISO 10993-6.

Download the biocompatibility test matrix. [Based on ISO 10993-1:2010 (E) and FDA G95-1 Guidelines]

Applicable Standards

  • ISO 10993-6

Test Options

Standard turn around times (TAT) are listed below. Ask an expert for a specific consultation on your product. If you are ready to submit your samples for testing, click here to fill out the Sample Submission Form.

Code Test TAT (days) Request Quote
SCX610 Implant Study: ISO 1 week, Surgical implant w/ histo, each 65 Add
SCX615 Implant Study: ISO 1 week, Subcutaneous w/ histo, each 65 Add
SCX620 Implant Study: ISO 2 week, Surgical implant w/ histo, each 56 Add
SCX625 Implant Study: ISO 2 week, Subcutaneous w/ histo, each 56 Add
SCX630 Implant Study: ISO 4 week, Surgical implant w/ histo, each 70 Add
SCX635 Implant Study: ISO 4 week, Subcutaneous w/ histo, each 70 Add
SCX640 Implant Study: ISO 8 week, Surgical implant w/ histo, each 105 Add
SCX645 Implant Study: ISO 8 week, Subcutaneous w/ histo, each 105 Add
SCX650 Implant Study: ISO 13 week, Surgical implant w/ histo, each 133 Add
SCX653 Implant Study: ISO 26 week, Surgical implant w/ histo (4 rabbits), each 230 Add
SCX655 Implant Study: ISO 13 week, Subcutaneous w/ histo, each 133 Add
SCX610 - Implant Study: ISO 1 week, Surgical implant w/ histo, each
TAT: 65 days
SCX615 - Implant Study: ISO 1 week, Subcutaneous w/ histo, each
TAT: 65 days
SCX620 - Implant Study: ISO 2 week, Surgical implant w/ histo, each
TAT: 56 days
SCX625 - Implant Study: ISO 2 week, Subcutaneous w/ histo, each
TAT: 56 days
SCX630 - Implant Study: ISO 4 week, Surgical implant w/ histo, each
TAT: 70 days
SCX635 - Implant Study: ISO 4 week, Subcutaneous w/ histo, each
TAT: 70 days
SCX640 - Implant Study: ISO 8 week, Surgical implant w/ histo, each
TAT: 105 days
SCX645 - Implant Study: ISO 8 week, Subcutaneous w/ histo, each
TAT: 105 days
SCX650 - Implant Study: ISO 13 week, Surgical implant w/ histo, each
TAT: 133 days
SCX653 - Implant Study: ISO 26 week, Surgical implant w/ histo (4 rabbits), each
TAT: 230 days
SCX655 - Implant Study: ISO 13 week, Subcutaneous w/ histo, each
TAT: 133 days

Sample Specifications

SCX610: 14, 1 x 1 x 10 mm strips. CSS Approval is needed to meet TAT.
SCX615: 14, 1 x 1 x 10 mm strips. CSS Approval is needed to meet TAT.
SCX620: 14, 1 x 1 x 10 mm strips. CSS Approval is needed to meet TAT.
SCX625: 14, 1 x 1 x 10 mm strips. CSS Approval is needed to meet TAT.
SCX630: 14, 1 x 1 x 10 mm strips. CSS Approval is needed to meet TAT.
SCX635: 14, 1 x 1 x 10 mm strips. CSS Approval is needed to meet TAT.
SCX640: 14, 1 x 1 x 10 mm strips. CSS Approval is needed to meet TAT.
SCX645: 14, 1 x 1 x 10 mm strips. CSS Approval is needed to meet TAT.
SCX650: 14, 1 x 1 x 10 mm strips. CSS Approval is needed to meet TAT.
SCX653: 20, 1 x 1 x 10 mm strips. CSS Approval is needed to meet TAT.
SCX655: 14, 1 x 1 x 10 mm strips. CSS Approval is needed to meet TAT.

Study Outline

In the Implantation with Histopathology test, representative portions of the device, or the entire device, are implanted in the paravertebral muscles of live rabbits for a predetermined exposure period. Gross necropsy observations will be made and implant sites harvested and fixed. Microscopic evaluation will include: cell type, cell distribution, fibroplasia and neovascularization.
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